Device Classification Name |
probe, radiofrequency lesion
|
510(k) Number |
K062937 |
Device Name |
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU |
Applicant |
BAYLIS MEDICAL CO., INC. |
2580 MATHESON BLVD. E |
MISSISSAUGA, ONTARIO,
CA
L4W 4J1
|
|
Applicant Contact |
MEGHAL KHAKHAR |
Correspondent |
BAYLIS MEDICAL CO., INC. |
2580 MATHESON BLVD. E |
MISSISSAUGA, ONTARIO,
CA
L4W 4J1
|
|
Correspondent Contact |
MEGHAL KHAKHAR |
Regulation Number | 882.4725
|
Classification Product Code |
|
Date Received | 09/28/2006 |
Decision Date | 01/08/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|